Decreasing Risk of Coronary Artery Disease in Schizophrenia by Omega-3 Fatty Acid Supplementation (CAD)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00167310|
Recruitment Status : Completed
First Posted : September 14, 2005
Results First Posted : April 10, 2017
Last Update Posted : April 10, 2017
|Condition or disease||Intervention/treatment||Phase|
|Schizophrenia Schizoaffective Disorder Major Depression Bipolar Disorder Coronary Artery Disease||Drug: Eicosapentaenoic acid (omega-3 fatty acid) Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||57 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||CAD Risk in Schizophrenia: Effect of Omega-3 Fatty Acid Supplementation|
|Study Start Date :||September 2005|
|Primary Completion Date :||December 2015|
|Study Completion Date :||December 2015|
U.S. FDA Resources
Eicosapentaenoic acid (omega-3 fatty acid, 2 g in 4x500 mg softgels daily) + Antipsychotic drug (doctor's choice) treatment for baseline, 1 month, 2 months and 4 months duration.
Drug: Eicosapentaenoic acid (omega-3 fatty acid)
2 g of Eicosapentaenoic acid in 4 x 500 mg capsules daily for baseline, 1 month, 2 months and 4 months
Other Name: EPA
Placebo Comparator: 2
Placebo (soy bean oil, 2 g in 4x500 mg softgels daily) + Antipsychotic drug (doctor's choice) treatment for baseline, 1 month, 2 months and 4 months duration.
2 g of Placebo (soy bean oil) in 4 x 500 mg capsules daily for baseline, 1 month, 2 months and 4 months
Other Name: Soy bean oil
- Plasma Levels of Triglycerides and Lipoprotein Cholesterol [ Time Frame: 4 months ]Biochemical measures: Plasma levels of triglycerides, small dense LDL (LDL3- and LDL4-) cholesterol, large buoyant LDL (LDL1- and LDL2-) cholesterol, and HDL2-cholesterol.
- Plasma Cholesterol Levels in Various Lipoprotein Fractions [ Time Frame: 4 months ]Biochemical Measures: Plasma levels of total cholesterol, LDL-cholesterol, HDL-cholesterol, VLDL-cholesterol, Lp(a) cholesterol, IDL-cholesterol, HDL3-cholesterol, VLDL1,2-cholesterol, and VLDL3-cholesterol.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00167310
|United States, Pennsylvania|
|VA Pittsburgh Healthcare System (University Drive)|
|Pittsburgh, Pennsylvania, United States, 15240|
|Principal Investigator:||Jeffrey K Yao, Ph.D., FACB||University of Pittsburgh and VA Pittsburgh Healthcare System|